KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia (NCT05421429) | Clinical Trial Compass
CompletedPhase 2
KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia
China24 participantsStarted 2022-07-07
Plain-language summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous doses of KN057 in subjects with hemophilia A or B, with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). 24 adult participants 18 to 70 years of age with moderately severe to severe hemophilia A or hemophilia B (defined as FVIII or FIX activity ≤2%, respectively) with or without inhibitors (including 18 HA/HB patients without inhibitors and 6 HA/HB patients with inhibitors) are expected to be enrolled in this study during which they will receive prophylaxis treatment (defined as treatment by SC injection once weekly of KN057).
Who can participate
Age range18 Years – 70 Years
SexMALE
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Inclusion criteria
✓. Male, 18-70 years old (including threshold), weight≥40kg;
✓. Moderately severe to severe hemophilia A or B (Factor VIII or Factor IX activity ≤2%)
✓. Participants who are enrolled into the Non-Inhibitor Cohort must meet the following criteria:
✓. Participants who are enrolled into the Inhibitor Cohort must meet the following criteria:
✓. Be willing to undergo a washout period of the original treatment regimen before the administration of KN057: at least 48 hours for recombinant activated coagulation factor Ⅶ (rFⅦa); at least 72 hours for FⅧ and prothrombin complex (PCC); at least 96 hours for FⅨ; For other drugs or investigational products with a long half-life, such as Emicizumab, at least five half-lives should have passed prior to dosing.
✓. Be willing to comply with the relevant management regulations of the clinical trial unit, and follow study procedures.
Exclusion criteria
✕. Patients with serious or poorly controlled chronic diseases or obvious systemic diseases, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, autoimmune diseases, nervous system diseases or psychiatric diseases, bacterial or viral infections, etc.; past or current lipid-lowering treatment for hypertriglyceridemia.
What they're measuring
1
Frequency and severity of treatment emergent adverse events(TEAEs)
Timeframe: Day 1 up to Day 85
2
Withdrawals due to TEAEs
Timeframe: Day 1 up to Day 85
3
Number of Participants With Abnormal Laboratory Findings-Hematology
Timeframe: Day 1 up to Day 85
4
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Timeframe: Day 1 up to Day 85
5
Number of Participants With Abnormal Laboratory Findings-Blood biochemistry
Timeframe: Day 1 up to Day 85
6
Number of Participants With Abnormal Laboratory Findings-Coagulation tests
Timeframe: Day 1 up to Day 85
7
Number of Participants With Clinically Significant Changes in Vital Signs Data
Timeframe: Day 1 up to Day 85
8
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
✕. Inherited or acquired bleeding disorder other than hemophilia A or B.
✕. Have symptoms or signs related to thromboembolic disease or are receiving thrombolytic/anti-thrombolytic therapy; A history of coronary atherosclerotic diseases, arterial or venous thrombosis, and ischemic diseases of important organs.
✕. Conditions that may increase risk of thrombosis: including reduced activity of antithrombin III, protein S or protein C;
✕. Must use PCC to treat acute bleeding episodes, and can't be treated with rFVIIa.
✕. Ongoing or planned use of immune tolerance induction.
✕. Regular use of immunomodulatory therapy, such as regular infusion of immunoglobulin or regular use of hormones.
✕. Allergy situation: Allergic to test drugs/similar drugs or excipients; With a history of multiple allergies (two or more); A history of specific reactions, such as sensitivity to heparin or heparin induced thrombocytopenia.
9
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Timeframe: Day 1 up to Day 85
10
Number of Participants With Injection Site Reactions